drugset / Trial / NCT01348386

Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum

NCT01348386

Phase 2/3 Completed 53 enrolled Jordi Gol Institute for Primary Care Research
RandomizedParallel-groupDouble-blindTreatment

Summary

BACKGROUND: Molluscum contagiosum is a non-serious children viral infection. Because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting. METHODS: A double blind, randomized clinical trial, in three groups of topic treatment is designed. The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10% and 15% concentration, versus a placebo administered to the control group. 4 follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and tolerance. The main target of the trial is to determine the healing rate, defined as lesion disappearance in the affected zones after the topic application of the treatment. Secondary targets are the main characteristics and evolution of the affected zone (surface, number of lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching, burning, pain), recurrence rate estimation and natural evolution of lesions in the control group.

Timeline

Start
2010-03
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject potassium hydroxide Small molecule 10 % Topical
Subject potassium hydroxide Small molecule 15 % Topical

Indications